Equipment Requalification Engineer

EFOR; Waterford; On-site; EUR 60,000 - 90,000; Full time

Job summary

EFOR Group, a Life Sciences consulting partner, is seeking an Equipment Requalification Engineer for Waterford, Ireland. This onsite, hands-on role focuses on assessing, writing, executing and reporting requalification protocols for sterile manufacturing equipment, alongside QA and equipment owners.

You will apply a risk-based FMEA approach, review status and records, and help implement the new requalification process across sites.

Qualifications

• Hands-on experience writing and executing qualification and requalification protocols (IQ/OQ/PQ)
• Periodic reviews of requalification records
• Risk-based approach to set scope and frequency (FMEA)

Responsibilities

• Assess equipment requalification practices vs global guidance
• Review requalification status, frequencies and records, identify gaps
• Apply risk-based approach to set scope and frequency for each system
• Write, execute and report requalification protocols with Engineering, QA and owners
• Work on sterile manufacturing equipment (autoclaves, depyrogenation, washers, isolators/RABS, filling, temperature-controlled units, CIP/SIP)
• Help implement new requalification process and hand over to routine operations

Skills

CQV/Validation experience

FMEA risk assessment

Autonomous/execution-focused

Documentation discipline

QA collaboration

Education

Engineering degree + CQV experience

Tools

Kneat

ValGenesis

Temperature mapping

Job description

Now Hiring: Equipment Requalification Engineer (Waterford, Ireland | Onsite)

Are you a CQV engineer who’s happiest on the floor, with a protocol in hand, next to an autoclave? EFOR Group, a trusted Life Sciences consulting partner, is looking for an Equipment Requalification Engineer to join a global pharmaceutical manufacturer in Waterford. The role is part of a network-wide programme to harmonise how equipment requalification is managed across sites. It’s hands‑on work: assess, write, execute, report and hand over.

What you’ll do:

• Assess the site’s equipment requalification practices and status against new global requalification guidance
• Review requalification status, frequencies and periodic review records, and identify gaps
• Apply a risk-based requalification approach (FMEA) to set the right scope and frequency for each system
• Write, execute and report requalification protocols with Engineering, QA and equipment owners
• Work on sterile manufacturing equipment: autoclaves, depyrogenation tunnels, washers, isolators/RABS, filling equipment, temperature‑controlled units and CIP/SIP systems
• Help put the new requalification process in place, hand it over to routine operations, and report progress to the global programme

Your background:

• Degree in Mechanical, Chemical, Process or Biomedical Engineering, or a science degree with strong CQV experience
• 3–7 years in CQV or validation in a GMP environment, ideally sterile or biologics manufacturing
• Hands‑on experience writing and executing qualification and requalification protocols (IQ/OQ/PQ), plus periodic reviews
• Strong knowledge of EU GMP Annex 15, ASTM E2500 / ISPE C&Q guidance, and risk assessment (FMEA)
• Experience with paperless validation tools (e.g. Kneat, ValGenesis) or thermal validation / temperature mapping is a plus
• Remediation or compliance‑improvement project experience is a strong plus
• Execution‑focused and autonomous, with rigorous documentation, and works well with Maintenance, Engineering and QA

Why EFOR Group?

EFOR brings together more than 3,200 experts in 18 countries, delivering technical, quality and engineering excellence across the full Life Sciences product lifecycle. Join a team helping to keep sterile manufacturing equipment in a proven, compliant state for patients.

Location: Waterford, Ireland (onsite)

Contract: approx. 7.5 months, starting November 2026

Ready to prove the equipment is still fit for purpose?

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